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Senior Director of Regulatory Affairs

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Collins McNicholas

“Senior Director of Regulatory Affairs ” – Permanent role –

Reporting to the Global Product Development Director and as part of a global team , The role as Senior Regulatory Affairs Director is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements. The Senior Regulatory Affairs Director reports to the Executive Director Product Development, Regulatory and Quality Affairs.

This is an opportunity to work in a key role with a broad spectrum of responsibilities in a small pharmaceutical company and to contribute to the growth of the company. The vision is to support and build the portfolio of products, where the regulatory function plays a crucial role in this activity.

The work is with international focus and performed in close cooperation with international development and licensing partners. Responsibilities include different therapeutic areas, compilation of full registration files, and direct contact with global regulatory authorities. The position also includes project management and international travelling. This is a new position within a fast moving innovative company, opportunity for growth/advancement are attainable and working on a broad product portfolio.

Responsibilities and main tasks:

Manage the activities of Drug Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies

Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy

Coordinate successful submissions and approval of all drug applications

Ensure that Global Regulatory standards are met and that the deliverables meet strict deadlines

Coordinate the writing, review and approval of corporate regulatory and quality procedures according to international GMP regulations and assure that the companies sites are implementing procedures in compliance with the corporate procedures

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